InfluenzaPhase 2/3NCT00972816
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)
A Phase 2/3 study testing MF59-eH1N1 in people with Influenza, run by Novartis Vaccines at 35 sites in 2 countries.
Trial summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- MF59-eH1N1
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,357 participants
- Where
- 35 sitesin 2 countries
- Study dates
- Sep 2009to Oct 2010
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 3 to < 9 years of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.
Who cannot join
- History of serious disease.
- History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
- Known or suspected impairment/alteration of immune function.
- Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
- For additional entry criteria, please refer to protocol.
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States34 sites
Heartland Research Associates LLC
Arkansas City, Kansas, 67005
The Portland Clinic LLP
Beaverton, Oregon, 97006
PI-Coor Clinical Research
Burke, Virginia, 22015
Dr. Senders and Associates, Pediatrics
Cleveland, Ohio, 44121
Research Across America
Dallas, Texas, 75234
Northern Illinois Research Associates
DeKalb, Illinois, 60115
Premier Health Research Center, LLC
Downey, California, 90241-4982
Children's Health Care -West
Erie, Pennsylvania, 16506
Prestige Clinical Research
Franklin, Ohio, 45005
UPMC/Community Medicine (pediatrics)
Greenville, Pennsylvania, 16125
Clinical Research Center of Nevada
Henderson, Nevada, 89015
West Houston Clinical Research Service
Houston, Texas, 77055
Pediatric Physicians Research, Inc.
Jefferson Hills, Pennsylvania, 15025
Holston Medical Group
Kingsport, Tennessee, 37660
Bluegrass Clinical Research, Inc (Brownsboro for drug shipment)
Louisville, Kentucky, 40291
Madera Family Medical Group
Madera, California, 93637
Pediatrics and Adolescent Medicine
Marietta, Georgia, 30062
Bluegrass Clinical Research, Inc.
New Albany, Indiana, 47150
Heartland Research Associates LLC
Newton, Kansas, 67114
IPS Research
Oklahoma City, Oklahoma, 73103
Meridien Clinical Research
Omaha, Nebraska, 68134
Center for Clincal Trials, LLC
Paramount, California, 90723
Center for Clinical Trials, LLC
Paramount, California, 90723
Pediatric Alliance - Greentree Division (pediatrics)
Pittsburgh, Pennsylvania, 15220
Capital Pediatrics and Adolescent Ctr.
Raleigh, North Carolina, 27609
Virginia Commonwealth University
Richmond, Virginia, 23219
J.Lewis Research, Inc./Foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research, Inc./Foothill Family Clinic South
Salt Lake City, Utah, 84121
Rockwood Research Center
Spokane, Washington, 99202
1st International Research Centers
Thornton, Colorado, 80233
Pediatric Healthcare of NW Houston
Tomball, Texas, 77375
Omega Clinical Research
Warwick, Rhode Island, 02886
Center for Clinical Trials of San Gabriel
West Covina, California, 91790
Pediatrics and Adolescent Medicine
Woodstock, Georgia, 30189
About this study
Official title: A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Pediatric Subjects 3 to < 9 Years of Age
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.
- Conditions
- Influenza
- Being tested
- MF59-eH1N1
- Keywords
- Swine Flu, Flu, Vaccine, Children, Adjuvant
- Medical subject headings
- Influenza, Human, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF59-eH1N1Biological
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
| Study group | Role | What they receive |
|---|---|---|
| 3.75_(50)MF59 | Experimental | 3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22 Receives: Biological: MF59-eH1N1 |
| 7.5_(0) MF59 | Experimental | 7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22 Receives: Biological: MF59-eH1N1 |
| 7.5_(50) MF59 | Experimental | 7.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22 Receives: Biological: MF59-eH1N1 |
| 7.5_(100) MF59 | Experimental | 7.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22 Receives: Biological: MF59-eH1N1 |
| 15_(0) MF59 | Experimental | 15 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22 Receives: Biological: MF59-eH1N1 |
| 15_(50)MF59 | Experimental | 15 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22 Receives: Biological: MF59-eH1N1 |
| 15_(100) MF59 | Experimental | 15 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22 Receives: Biological: MF59-eH1N1 |
| 30_(0) MF59 | Experimental | 30 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22 Receives: Biological: MF59-eH1N1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for <65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity.
PPS Day 1-29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively.
PPS Day 1-202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.
PPS Day 1-387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively.
Measured: Day 22, Day 29, Day 43, Day 202 and Day 387
Secondary outcomes (8)
Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group
Immunogenicity was measured in terms of GMTs After each vaccination by vaccine Group.
PPS Day1-29 analysis set: N=143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F, G, and H respectively.
PPS Day 1-202 analysis set. N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.
Measured: Day 22, Day 29, Day 43, Day 202 and Day 387
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Committee for Medicinal Products for Human Use (CHMP) guidance: in adults ages 18 to 60 years are:The percentage of subjects with seroconversion or significant increase in HI antibody is > 40%.The percentage of subjects achieving an HI titer ≥ 40 is > 70% and The GMR is > 2.5. All 3 criteria (seroconversion/significant increase, HI antibody titer ≥ 40, and GMR) had to be fulfilled to establish immunogenicity.Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.Subgroups without recent seasonal flu vaccine:PPS Day1, Day 1-22 and Day1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F, G,and H respectively.
Measured: Day 22, Day 29, Day 43
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Immunogenicity was measured in terms of GMTs of Subgroups with receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines
Subgroups without recent seasonal flu vaccine:
PPS Day 1, Day 1-22 and Day 1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively.
PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F,G, and H respectively.
Subgroups with recent seasonal flu vaccine:PPS Day 1-22 and Day 1-43 analysis set. N= 11, 9, 6, 8, 9, 11, 6, and 7 for Groups A, B, C, D, E, F, G,and H respectively.
PPS Day 1-29 analysis set. N= 11, 9, 6, 7, 9, 11, 5, and 6 for Groups A, B, C, D, E, F, G, and H respectively
Measured: Day 1, Day 22, Day 29, Day 43
Antibody Response Based on Baseline Seropositivity
Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline.
Subgroups with baseline HI titer < 1:10: PPS Day 1-29 analysis set. N= 104, 116, 111, 107, 109, 113,120, and 103 for Groups A, B, C, D, E, F, G, and H respectively.
Subgroups with baseline HI titer ≥ 1:10: PPS Day 1-29 analysis set. N= 39, 33, 38, 39, 38, 34, 24, and 41 for Groups A, B, C, D, E, F, G, and H respectively.
Measured: Day 22, Day 29 and Day 43
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline.
Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline [Day 1 (pre-vaccination)] as compared to those who are seronegative (HI titer < 1:10).
Measured: Day 1, Day 22, Day 29, Day 43
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Solicited local and systemic reactions were assessed after the first vaccination by vaccine group. Source Vocabulary Name: MedDRA (13.1).
Measured: 7 days after first vaccination
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Solicited local and systemic reactions were assessed after the second vaccination by vaccine group.Source Vocabulary Name: MedDRA (13.1)
Measured: 7 days after second vaccination
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Safety was measured in terms of the Number of Participants Reporting Unsolicited AEs. Source Vocabulary Name: MedDRA (13.1)
Measured: Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through ≤21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2009
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines and Diagnostics, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972816
- Sponsor's protocol ID
- V112_02
- Status last verified
- Mar 2016
- First submitted
- 2 Sep 2009
- Last updated
- 14 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Pediatric Subjects 3 to < 9 Years of Age
- ClinicalTrials.gov ID
- NCT00972816
- Acronym / sponsor ID
- V112_02
- Conditions
- Influenza
- Keywords
- Swine Flu, Flu, Vaccine, Children, Adjuvant
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,357 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 9 Sep 2009 (estimated)
- Results
- Posted 27 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 3.75_(50)MF59 | Experimental | Biological: MF59-eH1N13.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22 |
| 7.5_(0) MF59 | Experimental | Biological: MF59-eH1N17.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22 |
| 7.5_(50) MF59 | Experimental | Biological: MF59-eH1N17.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22 |
| 7.5_(100) MF59 | Experimental | Biological: MF59-eH1N17.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22 |
| 15_(0) MF59 | Experimental | Biological: MF59-eH1N115 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22 |
| 15_(50)MF59 | Experimental | Biological: MF59-eH1N115 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22 |
| 15_(100) MF59 | Experimental | Biological: MF59-eH1N115 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22 |
| 30_(0) MF59 | Experimental | Biological: MF59-eH1N130 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22 |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 3 to < 9 years of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.
Key exclusion criteria (5 listed)
- History of serious disease.
- History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
- Known or suspected impairment/alteration of immune function.
- Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
- For additional entry criteria, please refer to protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MF59-eH1N1MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus). | Biological | 15_(0) MF59, 15_(100) MF59, 15_(50)MF59, 3.75_(50)MF59, 30_(0) MF59, 7.5_(0) MF59, 7.5_(100) MF59, 7.5_(50) MF59 |
Primary outcome
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
Time frame: Day 22, Day 29, Day 43, Day 202 and Day 387
HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for <65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity. PPS Day 1-29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively. PPS Day 1-202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively.
8 secondary outcomes
Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group
Time frame: Day 22, Day 29, Day 43, Day 202 and Day 387
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
Time frame: Day 22, Day 29, Day 43
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Time frame: Day 1, Day 22, Day 29, Day 43
Antibody Response Based on Baseline Seropositivity
Time frame: Day 22, Day 29 and Day 43
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
Time frame: Day 1, Day 22, Day 29, Day 43
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Time frame: 7 days after first vaccination
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Time frame: 7 days after second vaccination
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Time frame: Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through ≤21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Vaccines and Diagnostics study director
Novartis
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MF59-eH1N1 in people with Influenza, run by Novartis Vaccines at 35 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations (time frame: Day 22, Day 29, Day 43, Day 202 and Day 387). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.